Back to resultsHeliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
heliox
oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring heliox, bronchiolitis, racemic epinephrine
Eligibility Criteria
Inclusion Criteria: Any child 2-12 months old seen in the emergency department. A clinical bronchiolitis score > 3 by modified Wood's Clinical Bronchiolitis Score (M-WCBS). Diagnostic criteria of bronchiolitis includes tachypnea, cough, prolonged expiratory phase, wheezing, rales, chest retractions, and hyperinflation of lungs on chest radiograph. After consenting a patient to the study, respiratory syncytial virus (RSV) infection will be tested by rapid enzyme-linked immunoabsorbent assay of nasal secretions. Exclusion Criteria: No child will be excluded based on race or gender Patients under the age of 2 months or greater than 12 months Patients with cyanotic heart disease Patients with lobar pneumonia, defined by results of chest radiographs. The presence of interstitial disease or diffuse patchy marking consistent with atelectasis on chest radiographs will not exclude patients. Patients with croup. Patients with foreign body aspiration. Patients with history of cystic fibrosis, bronchopulmonary dysplasia or other chronic lung disease. Patients with liver or renal disease. Patients with sickle cell anemia. Patients requiring mechanical ventilation. Patients who develop supraventricular tachycardia secondary to racemic epinephrine administration. Patients with tracheomalacia or bronchomalacia. Patients who had received bronchodilators within 2 hours of initiation of the study. Patients who had received systemic corticosteroids within 72 hours of enrollment Patients who suffered from persistent airway hyperreactivity in the 3 months before the study. Patients who do not tolerate the nasal cannulae for 45 out of 60 minutes.
Sites / Locations
- Kosair Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
heliox
oxygen
Arm Description
heliox-driven nebulizations for children with moderate to severe bronchiolitis
oxygen-driven nebulizations for children with moderate to severe bronchiolitis
Outcomes
Primary Outcome Measures
Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes
The Modified Wood's clinical Asthma Score is a score to measure severity of Asthma in children. There are 5 variables measured: oxygen saturation, inspiratory breath sounds, expiratory wheezing, accessory muscle involvement and cerebral function. Each variable is given a score of 0, 0.5, 1 or 2 with 2 being the most severe. The scores are combined from each variable to give a total. Total score ranges from 0 to 10, with a score of 10 (higher the score) indicating a worse outcome. We are reporting the degree of improvement in M-WCAS after assigned treatment.
Secondary Outcome Measures
Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times
The Modified Wood's Clinical Bronchiolitis Score is based on a rating of saturated oxygen, inspiratory breath sounds, expiratory wheezing, accessory muscle use, cerebral function and wheezing. Each variable is rated 0, 0.5, 1, or 2. The total range of score is 0 to 2, with 2 (higher the score) indicating a worse outcome. For this outcome, a negative difference between groups represents an improvement.
Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times
The RDAI is an assessment instrument for respiratory distress. Patients are assigned a point value based on Wheezing (on expiration, inspiration and location) and Retractions (local of supraclavicular, intercostal and subcostal). Each subcategory is assigned a value of 0-4. The subscores are summed to give a total score for each variable (wheezing and retractions). The total score range for wheezing is 0 to 8, with 8 (higher the score) indicating a worse outcome. The total score range for retractions is 0 to 9, with 9 (higher the score) indicating a worse outcome. We are reporting the difference in score between the groups at various times, not a change from an earlier time. A positive value represents an improvement in the Heliox vs the Oxygen groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00116584
Brief Title
Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients
Official Title
The Use of Heliox Driven Racemic Epinephrine Nebulization in the Treatment of Moderate to Severe Bronchiolitis in Pediatric Emergency Department Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess whether children with moderate to severe bronchiolitis treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven nebulization will have improvements in measurements of airway more rapidly than those treated with conventional air-oxygen driven nebulization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
heliox, bronchiolitis, racemic epinephrine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
heliox
Arm Type
Other
Arm Description
heliox-driven nebulizations for children with moderate to severe bronchiolitis
Arm Title
oxygen
Arm Type
Other
Arm Description
oxygen-driven nebulizations for children with moderate to severe bronchiolitis
Intervention Type
Drug
Intervention Name(s)
heliox
Intervention Description
continuous heliox therapy
Intervention Type
Drug
Intervention Name(s)
oxygen
Intervention Description
continuous oxygen therapy
Primary Outcome Measure Information:
Title
Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes
Description
The Modified Wood's clinical Asthma Score is a score to measure severity of Asthma in children. There are 5 variables measured: oxygen saturation, inspiratory breath sounds, expiratory wheezing, accessory muscle involvement and cerebral function. Each variable is given a score of 0, 0.5, 1 or 2 with 2 being the most severe. The scores are combined from each variable to give a total. Total score ranges from 0 to 10, with a score of 10 (higher the score) indicating a worse outcome. We are reporting the degree of improvement in M-WCAS after assigned treatment.
Time Frame
240 Minutes
Secondary Outcome Measure Information:
Title
Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times
Description
The Modified Wood's Clinical Bronchiolitis Score is based on a rating of saturated oxygen, inspiratory breath sounds, expiratory wheezing, accessory muscle use, cerebral function and wheezing. Each variable is rated 0, 0.5, 1, or 2. The total range of score is 0 to 2, with 2 (higher the score) indicating a worse outcome. For this outcome, a negative difference between groups represents an improvement.
Time Frame
0, 60, 120, 180 and 240 min
Title
Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times
Description
The RDAI is an assessment instrument for respiratory distress. Patients are assigned a point value based on Wheezing (on expiration, inspiration and location) and Retractions (local of supraclavicular, intercostal and subcostal). Each subcategory is assigned a value of 0-4. The subscores are summed to give a total score for each variable (wheezing and retractions). The total score range for wheezing is 0 to 8, with 8 (higher the score) indicating a worse outcome. The total score range for retractions is 0 to 9, with 9 (higher the score) indicating a worse outcome. We are reporting the difference in score between the groups at various times, not a change from an earlier time. A positive value represents an improvement in the Heliox vs the Oxygen groups.
Time Frame
0, 60, 120, 180 and 240 mins
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Any child 2-12 months old seen in the emergency department.
A clinical bronchiolitis score > 3 by modified Wood's Clinical Bronchiolitis Score (M-WCBS).
Diagnostic criteria of bronchiolitis includes tachypnea, cough, prolonged expiratory phase, wheezing, rales, chest retractions, and hyperinflation of lungs on chest radiograph. After consenting a patient to the study, respiratory syncytial virus (RSV) infection will be tested by rapid enzyme-linked immunoabsorbent assay of nasal secretions.
Exclusion Criteria:
No child will be excluded based on race or gender
Patients under the age of 2 months or greater than 12 months
Patients with cyanotic heart disease
Patients with lobar pneumonia, defined by results of chest radiographs.
The presence of interstitial disease or diffuse patchy marking consistent with atelectasis on chest radiographs will not exclude patients.
Patients with croup.
Patients with foreign body aspiration.
Patients with history of cystic fibrosis, bronchopulmonary dysplasia or other chronic lung disease.
Patients with liver or renal disease.
Patients with sickle cell anemia.
Patients requiring mechanical ventilation.
Patients who develop supraventricular tachycardia secondary to racemic epinephrine administration.
Patients with tracheomalacia or bronchomalacia.
Patients who had received bronchodilators within 2 hours of initiation of the study.
Patients who had received systemic corticosteroids within 72 hours of enrollment
Patients who suffered from persistent airway hyperreactivity in the 3 months before the study.
Patients who do not tolerate the nasal cannulae for 45 out of 60 minutes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In K Kim, MD
Organizational Affiliation
University of Louisville, Dept. of Pediatrics, Div. of Pediatric Emergency Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22147778
Citation
Kim IK, Phrampus E, Sikes K, Pendleton J, Saville A, Corcoran T, Gracely E, Venkataraman S. Helium-oxygen therapy for infants with bronchiolitis: a randomized controlled trial. Arch Pediatr Adolesc Med. 2011 Dec;165(12):1115-22. doi: 10.1001/archpediatrics.2011.605.
Results Reference
result
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Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients
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